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Cleaning and reprocessing products
EUDAMEDFDA UDIClass I (EU MDR)
Ref 38003Model 10000201124
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- Cleaning and reprocessing products EUDAMEDPERFORATED BASKET, UPPER URINARY TRACT 1 Holds: ureteroscope, nephroscope, for machine reprocessing, sterilization (steam and low-temperature), storage and transport, with holders for sonotrodes, with small part basket, inner dimensions (wxhxd): 619x65x124mm, outer dimensions (wxhxd): 635x75x132mm FDA UDI
- Model / Reference
- 10000201124 EUDAMED38003 EUDAMEDFDA UDI
- Description
- PERFORATED BASKET, UPPER URINARY TRACT 1 Holds: ureteroscope, nephroscope, for machine reprocessing, sterilization (steam and low-temperature), storage and transport, with holders for sonotrodes, with small part basket, inner dimensions (wxhxd): 619x65x124mm, outer dimensions (wxhxd): 635x75x132mm FDA UDI
Identifiers
- Catalog Number
- 38003 FDA UDI
- Primary DI / UDI-DI
- 04055207067611 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520727052019-0017742PN EUDAMED
- Direct Marketing DI
- 04055207067611 EUDAMED
- FDA Product Code
- KCT FDA UDI
- EMDN Code
- Z12011399 CLEANING, DISINFECTION AND STERILISATION INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6850 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Cleaning and reprocessing products by Richard Wolf GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 405520727052019-0017742PN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Richard Wolf GmbH
- EUDAMED SRN
- DE-MF-000007048
Sources (2)
- EUDAMED 0332c603-701f-4380-a801-0e51a5312220 61 fields · synced Jun 18, 2026
- FDA UDI 036277f9-3677-4ba7-a477-8eba344b03fb 36 fields · synced May 30, 2026